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Use of AlignRT System During Stereotactic Radiosurgery

15. juli 2026 opdateret af: Institute of Oncology Ljubljana
This prospective study evaluated whether the AlignRT surface-guided radiotherapy system improves patient positioning accuracy during stereotactic radiosurgery (SRS) for brain metastases compared with standard manual positioning. Twenty adults scheduled for single-fraction SRS were positioned twice before treatment. Participants were first positioned using the standard manual method with delta couch shift and were then positioned automatically using the AlignRT system. After each positioning method, a partial cone-beam computed tomography (CBCT) scan was performed to measure residual setup deviations in three translational and three rotational directions. The primary objective was to compare the average setup deviations between the two positioning methods and determine whether AlignRT provided more accurate patient positioning. The additional positioning and imaging procedure prolonged the treatment visit by up to 15 minutes and involved a low additional imaging dose.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This was a prospective, single-group clinical study conducted at the Institute of Oncology Ljubljana. The study included adult patients with brain metastases who were scheduled to receive single-fraction stereotactic radiosurgery using the TrueBeam STx linear accelerator.

Each participant underwent two positioning procedures before treatment. Standard manual positioning was performed using the delta couch shift function, followed by partial CBCT verification. The participant was then positioned automatically using the AlignRT surface-guided radiotherapy system, followed by a second partial CBCT verification.

Residual positioning deviations were recorded in three translational directions (vertical, longitudinal, and lateral) and three rotational directions (rotation, pitch, and roll). The average deviations obtained after manual positioning were compared with those obtained after AlignRT-guided positioning. Additional analyses considered participant age and sex. Positioning data were obtained from the ARIA information system and analyzed using Microsoft Excel and IBM SPSS.

A total of 20 participants completed the study. No additional follow-up was required after completion of the positioning measurements.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Slovenien
      • Ljubljana, Slovenien, 1000
        • Institute of Oncology Ljubljana

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • Adults aged 18 years or older
  • Patients with brain metastases eligible for single-fraction stereotactic radiosurgery
  • Treatment performed using the TrueBeam STx linear accelerator
  • Able and willing to provide written informed consent.

Exclusion Criteria:

  • Patients younger than 18 years
  • Patients receiving fractionated stereotactic radiotherapy
  • Treatment performed using a linear accelerator other than TrueBeam STx.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Manual and AlignRT-Guided Positioning
Participants underwent standard manual positioning followed by automatic positioning using the AlignRT system before stereotactic radiosurgery. A partial cone-beam computed tomography scan was performed after each positioning method to measure residual translational and rotational setup deviations.
Andet: Manual Patient Positioning
Participants were manually positioned from the initial setup position to the treatment isocenter using the delta couch shift function. A partial cone-beam computed tomography scan was then performed to measure residual setup deviations in three translational and three rotational directions.
Andet: AlignRT-Guided Patient Positioning
Participants were automatically positioned at the treatment isocenter using the AlignRT surface-guided radiotherapy system. A partial cone-beam computed tomography scan was then performed to measure residual setup deviations in three translational and three rotational directions.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Residual Translational Setup Deviations After Manual and AlignRT-Guided Positioning
Tidsramme: Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.
Residual setup deviations measured by partial cone-beam computed tomography in the vertical, longitudinal, and lateral directions, expressed in centimeters. Mean deviations were compared between manual positioning and AlignRT-guided positioning within the same participants.
Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.
Residual Rotational Setup Deviations After Manual and AlignRT-Guided Positioning
Tidsramme: Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.
Residual setup deviations measured by partial cone-beam computed tomography for rotation, pitch, and roll, expressed in degrees. Mean deviations were compared between manual positioning and AlignRT-guided positioning within the same participants.
Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Difference in Absolute Translational Setup Deviations Between AlignRT-Guided and Manual Positioning
Tidsramme: Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.
Within-participant comparison of the absolute residual setup deviations measured in the vertical, longitudinal, and lateral directions after AlignRT-guided positioning and manual positioning. Deviations were expressed in centimeters. Smaller absolute deviations indicate greater positioning accuracy.
Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.
Difference in Absolute Rotational Setup Deviations Between AlignRT-Guided and Manual Positioning
Tidsramme: Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.
Within-participant comparison of the absolute residual setup deviations measured for rotation, pitch, and roll after AlignRT-guided positioning and manual positioning. Deviations were expressed in degrees. Smaller absolute deviations indicate greater positioning accuracy.
Immediately after each positioning procedure and before stereotactic radiosurgery, during the same treatment visit.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Institute of Oncology Ljubljana

Efterforskere

  • Ledende efterforsker: Klemen Salmič, MSc, Institute of Oncology Ljubljana

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2025

Primær færdiggørelse (Faktiske)

31. august 2025

Studieafslutning (Faktiske)

31. august 2025

Datoer for studieregistrering

Først indsendt

15. juli 2026

Først indsendt, der opfyldte QC-kriterier

15. juli 2026

Først opslået (Faktiske)

21. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ERIDNPVO-0017/2025

Plan for individuelle deltagerdata (IPD)

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